Fractional Wearables Lead

Location: Chicago, IL — Hybrid / On-site for lab testing

Type: Fractional Contract / Contract-to-HireTarget Start: Immediate — Q3/Q4 2026⚠️ CRITICAL GATEKEEPERTo save everyone's time, we are only considering candidates who have personally shipped a regulated medical wearable (Class II or Class III) through FDA clearance or CE Mark approval and have hands-on experience authoring IEC 62366 usability engineering documentation. General consumer product design, non-regulated wearables, or pure software/cloud experience will not meet the technical requirements of this clinical hardware role.

Role Overview: We are seeking a highly specialized Fractional Wearables Lead to own the physical patient-to-device interface for our next-generation EEG wearable patch. This role will be critical to achieving medical-grade EEG signal integrity, reliable device performance, and patient comfort during continuous, multi-day wear.

Key Responsibilities: Electrode & Materials Engineering: Lead the selection and evaluation of medical-grade adhesives and wearable materials. Characterize and optimize skin-electrode impedance stability and develop solutions to minimize motion artifacts. Mechanical & Form Factor Design: Design, prototype, and iterate on wearable form factors, including patch and behind-the-ear configurations, while optimizing retention, comfort, and usability across diverse skin and hair types. Human Factors & Usability: Lead usability engineering activities in accordance with IEC 62366. Design intuitive donning and doffing workflows for patients and caregivers and author usability documentation for FDA and other regulatory submissions. Cross-Functional Collaboration: Work closely with electrical engineering, firmware, analog front-end, clinical, and regulatory teams. Support biocompatibility testing in accordance with ISO 10993 and contribute to regulatory submissions. Clinical Build Support: Support the assembly and testing of our first clinical-build wearable patch and contribute to the design of early clinical studies planned for late 2026.Hard Gatekeeper Requirements Candidates must meet all of the following requirements: Regulated Medical Wearables: Personally shipped at least one regulated Class II or Class III medical wearable—such as a CGM, ECG/EEG patch, or smart hearable—that successfully achieved FDA clearance or CE Mark approval. Hands-On Usability Engineering: Proven experience authoring IEC 62366 usability engineering files/documentation for an actual regulatory submission. Electrode & Adhesive Expertise: Deep technical expertise in skin-electrode interface physics, impedance characterization/testing, motion-artifact mitigation, and medical adhesive behavior. Hardware Engineering Experience: Hands-on experience with the physical design, testing, prototyping, and validation of medical wearables. Location & Availability: Ability to support hardware testing and collaborate with our Chicago-based engineering lab as needed. This is a hands-on engineering role, not a high-level project management position. Candidates who do not meet the hard gatekeeper requirements above will not be considered.